Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W

Q: Who is the manufacturer of Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

Iray Technology Taicang , Ltd. filed the 510(k) submission for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W (K201004).

Q: What is the FDA product code for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K201004 · Iray Technology Taicang , Ltd. · MQB · May 1, 2020 · Radiology

Device Facts

Record ID	K201004
Device Name	Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
Applicant	Iray Technology Taicang , Ltd.
Product Code	MQB · Radiology
Decision Date	May 1, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended Use

Mars1417V-TSI wireless digital flat panel detector and Mano4336W wireless digital flat panel detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.

Device Story

Wireless digital flat panel detectors (Mars1417V-TSI, Mano4336W) capture X-ray images for general radiography. Device uses CsI scintillator to convert X-rays to visible light, then TFT/diode capacitor array to transform light into electron signals. Signals processed and transmitted to PC via user interface/SDK. Operated by DR system manufacturers/technicians in clinical settings. Includes AED trigger module to detect X-ray exposure and initiate image acquisition. Output is digital X-ray image used by clinicians for diagnosis of disease or injury. Benefits include digital imaging workflow, replacing film/screen systems.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC/ES 60601-1), EMC (IEC 60601-1-2), and biological evaluation (ISO 10993-1).

Technological Characteristics

CsI scintillator; TFT/diode capacitor array; 16-bit ADC; wireless (IEEE 802.11a/b/g/n/ac) and wired (Gigabit Ethernet) connectivity; carbon fiber housing; air cooling; 34.56cm x 42.00cm active area; 150μm pixel pitch.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in adult and pediatric patients. Replaces film/screen systems in general-purpose diagnostic procedures. Not for mammography or dental applications.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Wireless Digital Flat Panel Detector (Mars1417XF-CSI) (K182551)

Related Devices

K220668 — Wireless Digital Flat Panel Detector · Iray Technology Taicang , Ltd. · Apr 1, 2022
K201043 — Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) · Iray Technology Taicang , Ltd. · May 12, 2020
K182551 — Wireless Digital Flat Panel Detector · Iray Technology Taicang , Ltd. · Oct 17, 2018
K213646 — Focus HD 35 Detector · Iray Technology Taicang , Ltd. · Mar 29, 2022
K182550 — Wireless Digital Flat Panel Detector · Iray Technology Taicang , Ltd. · Oct 17, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ May 1, 2020 Image /page/0/Picture/1 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized caduceus. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. iRay Technology Taicang Ltd. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA #### Re: K201004 Trade/Device Name: Wireless Digital Flat Panel Detector (Models, Mars1417V-TSI, Mano4336W) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: April 10, 2020 Received: April 23, 2020 #### Dear Meng Li: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K201004 Device Name Wireless Digital Flat Panel Detector #### Indications for Use (Describe) Mars 1417V-TSI wireless digital flat panel detector and Mano436W wireless digital flat panel detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS (As Required by 21 CFR 807.92) K201004 - 1. Date Prepared [21 CFR 807.92(a)(1)] April 29th, 2020 ### 2. Submitter's Information [21 CFR 807.92(a)(1)] | Company Name: | iRay Technology Taicang Ltd. | | |------------------|---------------------------------------------------------------------------------------------------------|--| | Company Address: | No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone, Jiangsu, China 215434 | | | Contact Person: | Meng Li | | | Phone: | 0512-53690872 | | | Fax: | 0512-53690872 | | | Email: | meng.li@iraygroup.com | | ### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name: | Wireless Digital Flat Panel Detector | |----------------------|--------------------------------------| | Common Name: | Solid State X-Ray Imager | | Model Name: | Mars1417V-TSI | | | Mano4336W | | Classification Name: | Stationary X-Ray System | | Product Code: | MQB | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | {4}------------------------------------------------ #### 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[ The identification predicates within this submission are as follows: | Manufacturer: | iRay Technology Taicang Ltd. | |----------------------|--------------------------------------| | Trade Name: | Wireless Digital Flat Panel Detector | | Model Name: | Mars1417XF-CSI | | Product Code: | MQB | | Classification Name: | Stationary X-Ray System | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | | FDA 510 (k) #: | K182551 | #### 5. Description of the Device [21 CFR 807.92(a)(4)] Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detectors (Hereinafter referred to as Mars1417V-TSI and Mano4336W) are the kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Mars1417V-TSI and Mano4336W are totally same except for label and model name. The sensor plate of Mars1417V-TSI and Mano4336W is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Mars1417V-TSI and Mano4336W is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers. {5}------------------------------------------------ ### 6. Intended Use [21 CFR 807.92(a)(5)] #### 6.1. Indications for use Mars1417V-TSI wireless digital flat panel detector and Mano4336W wireless digital flat panel detector are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications. ### 6.2. Suitable patient It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system. #### 6.3. Processing of input and output When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem. | Item | Predicate Device: | Proposed Device: | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Wireless Digital Flat Panel Detector | Wireless Digital Flat Panel Detector | | 510(K) Number | K182551 | To be assigned | | Intended Use | The Mars1417XF-CSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic | same | | | Predicate Device: | Proposed Device: | | Item | Wireless Digital Flat Panel Detector | Wireless Digital Flat Panel Detector | | Indications for Use | system in all general-purpose diagnostic procedures. The Mars1417XF-CSI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. We understand the Agency has become aware of situations where solid state detectors inserted into radiographic systems adversely impacted device performance due to improper integration (reference:http://www.fda.gov/ downloads/MedicalDevices/Re sourcesforYou/Industry/UCM3 85149.pdf ). Below is a summary of the information from the Mars1417XF-CSI user manuals covering key electromechanical | Same with Mars1417XF-CSI, additionally, in the consideration of patient size (i.e., height, weight, body part thickness) and usable dose range, the detector could be used for general X ray diagnosis of usual body part for both adults and pediatric patients. | | Item | Predicate Device: | Proposed Device: | | | Wireless Digital Flat Panel Detector | Wireless Digital Flat Panel Detector | | | and computer requirements needed for X-ray system interface and integration. 1. Mechanical interface requirements. 2. Computer requirements 3. Data communication interface requirements 4. Electrical power requirements 5. X-ray trigger interface requirements Neither the Mars1417XF-CSI detector nor its software act as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements. | | | Classification Name | Stationary X-ray system | Same | | Product Code | MQB | Same | | Regulation Number | 21 CFR 892.1680 | Same | | Panel: | Radiology | Same | | | Predicate Device: Wireless Digital Flat Panel Detector | Proposed Device: Wireless Digital Flat Panel Detector | | Item | | | | Classification: | II | Same | | X-Ray Absorber (Scintillator): | CsI | Same | | Installation Type: | Wireless, Portable | Same | | Readout Mechanism: | Thin Film Transistor | Same | | Image Matrix Size: | 2336× 2836 pixels | 2304 × 2800 pixels | | Pixel Pitch: | 150μm | Same | | ADC Digitization | 16 bit | Same | | Effective Imaging Area: | 350.4 mm × 425.4 mm | 345.6 mm × 420.0 mm | | Spatial Resolution: | Min. 3.3lp/mm | Same | | Modulation Transfer Function (MTF) | 0.5 at 1 lp/mm | 0.68 at 1 lp/mm | | Detective Quantum Efficiency (DQE) | 0.37 at 1 lp/mm (RQA5, 2.5µGy) | 0.36 at 1 lp/mm (RQA5, 2.5µGy) | | Power Consumption: | Max. 19W | Max. 18W | | Item | Predicate Device: Wireless Digital Flat Panel Detector | Proposed Device: Wireless Digital Flat Panel Detector | | Communications: (Wireless functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | a) Wired (only for service) : Gigabit Ethernet (1000BASE-T) b) Wireless: IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) | | Imaging protect Plate: | Carbon Fiber Plate | Same | | Cooling: | Air cooling | Same | | Dimensions: | 384 mm × 460 mm × 15 mm | Same | | Operation: | Temperature: +5 ~ +30°C Humidity: 10 ~ 80% (Non-Condensing) Atmospheric pressure: 70 ~ 106 kPa Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C Humidity: 10 ~ 90% (Non-Condensing) Atmospheric pressure: 70 ~ 106 kPa Altitude: Max. 3000 meters | | Storage and Transportation: ( detector ) | Temperature: -20 ~ +50°C Humidity: 10 ~ 90% (Non-Condensing) Atmospheric pressure: 70 ~ 106 kPa Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C Humidity: 5 ~ 95% (Non-Condensing) Atmospheric pressure: 70 ~ 106 kPa Altitude: Max. 3000 meters | | Software | iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer | Same | | | Predicate Device: | Proposed Device: | | Item | Wireless Digital Flat Panel Detector | Wireless Digital Flat Panel Detector | | | control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers. | | | Utilized FDA guidance documents | 1. Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; 2. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications[510(k)]; 3. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; 4. Radio Frequency Wireless Technology in Medical Devices. | Same with Mars1417XF-CSI, additionally: 1. Guidance for "Premarket Assessment of Pediatric Medical Devices"; 2. Guidance for "Pediatric Information for X-ray Imaging Device Premarket Notifications". | ### 7. Technological Characteristic [21 CFR 807.92(a)(6)] {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ### 8. System requirements to operate with other radiographic system components - 1) Recommended Generator Specification: Energy range: 40~150kVp mA range: 10~1000mA (depending on the generator power) {11}------------------------------------------------ ms range: 10~6300ms to produce 0.1~1000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact the distributor or iRay's service office. - 2) Application Program Interface (API) for system integration manufacturer Peripheral hardware: Mars1417V-TSI and Mano4336W connected via wireless communication. | Operating System: | Windows 7 32/64bit | |-------------------|------------------------------------------------------------------------| | CPU: | Intel Core i7 3.6G | | Memory: | 4G DDR3 | | Hard Disk: | 640 G | | LAN Card: | Intel Pro EXP9301CT PRO Gigabit Network Adapter with PCIe interface | - 3) X-ray exposure mode The AED trigger module is a unit can connect X-ray signal in the Mars1417V-TSI/Mano4336W. Once there is X-ray generator exposure exist, the AED trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image. #### 9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)| - 1) Electrical Safety and EMC testing: Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements. - 2) Biological Evaluation: {12}------------------------------------------------ The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device. - 3) Non-clinical Considerations: One modification from the predicate device to Mars1417V-TSI and Mano4336W is geometric design, related to Amorphous Silicon (A-Si) panel size. Another modification is wireless functionality, predicate device has higher wireless transmission speed. The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551). - 4) Clinical Consideration: Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence. #### 10. Conclusion [21 CFR 807.92(b)(3)] In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. Concludes that Mars1417V-TSI and Mano4336W are substantially equivalent to predicate device with regards to safety and effectiveness.